# K092828: Statnet, Model 3100

- Pathway: 510(k) (Traditional)
- Applicant: Hydrodot, Inc.
- Decided: Jan 29, 2010 after 137 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171459: Ceribell Instant EEG Headband (2017), 21 descendants of its own
- K183529: AE-120A EEG Head Set (2019), 9 descendants of its own
- K210805: Ceribell Instant EEG Headband (2021), 5 descendants of its own
- K202334: Neuronaute (2020), 4 descendants of its own
- K232052: Ceribell Instant EEG Headband (2023), 3 descendants of its own

## Indications for use
An Electroencepahiogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.

Source page: https://510kreport.com/device/K092828
Methodology: https://510kreport.com/methodology